Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery.

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Third Molar Extraction Surgery

Treatments: Drug: Amoxilan; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05142449

AMOXI

Details and patient eligibility

About

59 medically healthy patients, who are scheduled for third molar extraction surgery and give informed consent for the trial, are operated using a split-mouth technique.

One group of patients will be assigned to the test group (Amoxilan) for the first surgery and to the control group (placebo) for the second surgery, and vice versa, according to randomisation.

Patients receive 8 capsules Amoxilan or placebo (according to randomisation) perioperatively, and 6 capsules Amoxilan/placebo per day for 3 days postoperativeley.

Enrollment: 59 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptom-free, bilaterally located third molars
• Medically healthy patient ≥ 16 years
• No allergies/intolerances against the investigational product/placebo
• Informed consent

Exclusion criteria

• General contraindications to wisdom tooth extraction surgery
• (Former) heavy smoking
• Use of antibiotics within the last three months or patients requiring antibiotic treatment prior to surgery
• (Planned) Pregnancy/lactating

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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59 participants in 2 patient groups, including a placebo group

Amoxilan

Experimental group

Description:

Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day.

Treatment:

Drug: Amoxilan

Placebo

Placebo Comparator group

Description:

Patients receive 8 capsules Placebo perioperatively and for the next 3 days 6 capsules per day.

Treatment:

Other: Placebo